"The problem with insulin costs is that the government will shoot anyone who tries to make cheap insulin." https://t.co/hmVWCTuT3V
No, they don't need the full clinical trial process, but they do often have to be tested on patients to show that they have the same bioavailability as the brand-name drug.
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I don't think bioequivalence certification requires human trials. IIRC bioequivalence studies involve spectroscopy, testing particle sizes, and tests on animals.
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